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Prescription Drugs: Executive Order Aims to Lower Prices

On April 15, 2025, President Trump signed an executive order (EO) with the aim of reducing the cost of prescription drugs....more

Massachusetts: New Year, New Law — Governor Signs “An Act enhancing the market review process” (House Bill No. 5159)

On January 8, 2025, Governor Maura Healey signed into law H.B. 5159, “an Act enhancing the market review process.” This new law promises sweeping reform to reshape how health care businesses operate and grow...more

AI-Enabled Device Software Functions: FDA’s Final Guidance for Predetermined Change Control Plans

On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-Enabled Device Software Functions (AI-DFS) final...more

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